Sep 30 2009
Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today announced it has received notice from Sun Pharma Global FZE advising that Sun has submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) for approval to market 100, 200 and 300 mg generic versions of Ryzolt(TM) (tramadol hydrochloride extended-release 100, 200 and 300 mg tablets) in the United States.
Under the Drug Price Competition and Patent Term Restoration Act (known as the Hatch-Waxman Act), Ryzolt has a new dosage form market exclusivity period that prevents final approval of Sun's ANDA until the exclusivity period expires on December 31, 2011.
Sun's ANDA includes a paragraph IV certification to obtain approval to manufacture, use, or sell its generic versions before the expiration of Patent Nos. 5,591,452, 6,254,887 and 6,607,748. U.S. Patent Nos. 5,591,452 and 6,254,887, which are owned by Purdue Pharma Products L.P., Labopharm's marketing and distribution partner in the US, expire in May 2014. U.S. Patent No. 6,607,748, which is owned by Labopharm, expires in June 2020. All three patents are listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluation (the "Orange Book").
Labopharm is currently reviewing the notice letter with Purdue to determine the next steps in this matter.
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